[Federal Register Volume 64, Number 16 (Tuesday, January 26, 1999)]
[Rules and Regulations]
[Pages 3865-3869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1765]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6224-7]
RIN 2060-AG12


Protection of Stratospheric Ozone: Listing Hexafluoropropylene 
(HFP) and HFP-Containing Blends as Unacceptable Refrigerants Under 
EPA's Significant New Alternatives Policy (SNAP) Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

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SUMMARY: With this action, EPA's Significant New Alternatives Policy 
(SNAP) program lists as unacceptable for all refrigeration and air-
conditioning end-uses hexafluoropropylene (HFP) and any blend 
containing HFP. Today's action responds to EPA's recent discovery of 
toxicity data concerning HFP, which present significant concerns about 
risks to human health that may arise as a result of exposure to HFP, 
either as a single chemical or in a blend, in the refrigeration and 
air-conditioning sector. Therefore, EPA is listing HFP and all HFP-
containing blends as unacceptable substitutes for CFC-12 and HCFC-22 in 
this sector.

DATES: Effective Date: This action is effective January 26, 1999. 
Comments: EPA will consider all written comments received by February 
25, 1999 to determine if any change to this action is necessary.

ADDRESSES: Information relevant to this notice is contained in Air 
Docket A-91-42, Central Docket Section, South Conference Room 4, U.S. 
Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 
20460, telephone: (202) 260-7548. The docket may be inspected between 
8:00 a.m. and 5:30 p.m. weekdays. As provided in 40 CFR Part 2, a 
reasonable fee may be charged for photocopying. Those wishing to notify 
EPA of their intent to submit adverse comments on this action should 
contact Kelly Davis, U.S. EPA, Stratospheric Protection Division, 
Office of Atmospheric Programs, Office of Air and Radiation (6205-J), 
401 M Street, S.W., Washington, DC 20460, (Docket # A-91-42), (202)-
564-2303.

FOR FURTHER INFORMATION CONTACT: Kelly Davis, U.S. EPA, Stratospheric 
Protection Division, Office of Atmospheric Programs, Office of Air and 
Radiation (6205-J), 401 M Street, S.W., Washington, DC, 20460, (202)-
564-2303 or electronically at [email protected]. General information 
about EPA's SNAP program can be found by calling EPA's Stratospheric 
Ozone Protection Hotline at (800) 296-1996 or by viewing EPA's SNAP 
Program world wide web site at www.epa.gov/ozone/title6/snap/snap.html.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Section 612 Program
    A. Statutory Requirements
    B. Regulatory History Background
    C. Listing of Substitutes
    D. Necessity for Interim Final Rule
II. Listing of HFP and HFP-Containing Blends as Unacceptable
III. Summary of Supporting Analyses
    A. Unfunded Mandates Reform Act and Regulatory Flexibility Act
    B. Executive Order 12866: Review of Significant Regulatory 
Actions by OMB
    C. Paperwork Reduction Act
    D. Executive Order 12875: Enhancing Intergovernmental 
Partnerships
    E. Submission to Congress and the General Accounting Office
    F. Executive Order 13045: Children's Health Protection
    G. Executive Order 13084: Consultation and Coordination With 
Indian Tribal Governments
IV. Additional Information

I. Section 612 Program

A. Statutory Requirements

    Section 612 of the Clean Air Act authorizes EPA to develop a 
program for evaluating alternatives to ozone-depleting substances. EPA 
refers to this program as the Significant New Alternatives Policy 
(SNAP) program. The major provisions of section 612 are:
     Rulemaking--Section 612(c) requires EPA to promulgate 
rules making it unlawful to replace any class I (chlorofluorocarbon, 
halon, carbon tetrachloride, methyl chloroform, methyl bromide, and 
hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance 
with any substitute that the Administrator determines may present 
adverse effects to human health or the environment where the 
Administrator has identified an alternative that (1) reduces the 
overall risk to human health and the environment, and (2) is currently 
or potentially available.
     Listing of Unacceptable/Acceptable Substitutes--Section 
612(c) also requires EPA to publish a list of the substitutes 
unacceptable for specific uses. EPA must publish a corresponding list 
of acceptable alternatives for specific uses.

[[Page 3866]]

     Petition Process--Section 612(d) grants the right to any 
person to petition EPA to add a substance to or delete a substance from 
the lists published in accordance with section 612(c). The Agency has 
90 days to grant or deny a petition. Where the Agency grants the 
petition, EPA must publish the revised lists within an additional six 
months.
     90-day Notification--Section 612(e) requires EPA to 
require any person who produces a chemical substitute for a class I 
substance to notify the Agency not less than 90 days before new or 
existing chemicals are introduced into interstate commerce for 
significant new uses as substitutes for a class I substance. The 
producer must also provide the Agency with the producer's unpublished 
health and safety studies on such substitutes.
     Outreach--Section 612(b)(1) states that the Administrator 
shall seek to maximize the use of federal research facilities and 
resources to assist users of class I and II substances in identifying 
and developing alternatives to the use of such substances in key 
commercial applications.
     Clearinghouse--Section 612(b)(4) requires the Agency to 
set up a public clearinghouse of alternative chemicals, product 
substitutes, and alternative manufacturing processes that are available 
for products and manufacturing processes which use class I and II 
substances.

B. Regulatory History Background

    On March 18, 1994, EPA published the Final SNAP Rule (59 FR 13044) 
which described the process for administering the SNAP program and 
issued EPA's first acceptability lists for substitutes in the major 
industrial use sectors. These sectors include: refrigeration and air 
conditioning; foam blowing; solvent cleaning; fire suppression and 
explosion protection; sterilants; aerosols; adhesives, coatings and 
inks; and tobacco expansion. These sectors compose the principal 
industrial sectors that historically consumed the largest volumes of 
ozone-depleting compounds.
    The Agency defines a ``substitute'' as any chemical, product 
substitute, or alternative manufacturing process, whether existing or 
new, that could replace a class I or class II substance. Anyone who 
produces a substitute must provide the Agency with health and safety 
studies on the substitute at least 90 days before introducing it into 
interstate commerce for significant new use as an alternative. This 
requirement applies to chemical manufacturers, but may include 
importers, formulators or end-users when they are responsible for 
introducing a substitute into commerce.

C. Listing of Substitutes

    To develop the lists of unacceptable and acceptable substitutes, 
EPA conducts screens of health and environmental risks posed by various 
substitutes for ozone-depleting compounds in each use sector. The 
outcome of these risk screens can be found in the public docket.
    Under section 612, the Agency has considerable discretion in the 
risk management decisions it can make under the SNAP program. The 
Agency has identified five possible decision categories: acceptable, 
acceptable subject to use conditions; acceptable subject to narrowed 
use limits; unacceptable; and pending. Acceptable substitutes can be 
used for all applications within the relevant sector end-use. 
Conversely, it is illegal to replace an ozone-depleting substitute with 
a substitute listed by SNAP as unacceptable for that end-use. A pending 
listing represents substitutes for which the Agency has not received 
complete data or has not completed its review of the data.
    After reviewing a substitute, the Agency may make a determination 
that a substitute is acceptable only if certain conditions of use are 
met to minimize risks to human health and the environment. Such 
substitutes are described as ``acceptable subject to use conditions.'' 
Use of such substitutes without meeting associated use conditions 
renders these substitutes unacceptable and subjects the user to 
enforcement for violation of section 612 of the Clean Air Act.
    Even though the Agency can restrict the use of a substitute based 
on the potential for adverse effects, it may be necessary to permit a 
narrowed range of use within a sector end-use because of the lack of 
alternatives for specialized applications. Users intending to adopt a 
substitute acceptable with narrowed use limits must ascertain that 
other acceptable alternatives are not technically feasible. Companies 
must document the results of their evaluation, and retain the results 
on file for the purpose of demonstrating compliance. This documentation 
shall include descriptions of substitutes examined and rejected, 
processes or products in which the substitute is needed, reason for 
rejection of other alternatives, e.g., performance, technical or safety 
standards, and the anticipated date other substitutes will be available 
and projected time for switching to other available substitutes. Use of 
such substitutes in applications and end-uses which are not specified 
as acceptable in the narrowed use limit renders these substitutes 
unacceptable.
    As described in the Final SNAP Rule, EPA does not believe that 
rulemaking procedures are required to list alternatives that are 
determined to be acceptable with no limitations. Such listings do not 
impose any sanction, nor do they remove any prior license to use a 
substitute. Consequently, EPA periodically adds substitutes to the list 
of acceptable alternatives without first requesting comment on new 
listings. Updates to the acceptable and pending lists are published in 
separate Notices in the Federal Register.
    Also as described in the Final SNAP Rule, EPA believes that notice-
and-comment rulemaking is required to place any alternative on the list 
of prohibited substitutes, to list a substitute as acceptable only 
under certain use conditions or narrowed use limits, or to remove an 
alternative from either the list of prohibited or acceptable 
substitutes. In this interim final rule, however, EPA is listing HFP 
and HFP-containing blends as unacceptable in all refrigeration and air-
conditioning end-uses, without prior notice and comment. The reasons 
for the Agency's decision to do so in an interim final rule rather than 
in a notice-and-comment rulemaking are discussed in section D below.

D. Necessity for Interim Final Rule

    Section 307(d)(3) of the Clean Air Act (CAA or the Act) states that 
in the case of any rule to which section 307(d) applies, notice of 
proposed rulemaking must be published in the Federal Register. The 
promulgation or revision of regulations under Title VI of the CAA 
(relating to stratospheric ozone protection) is generally subject to 
section 307(d). However, section 307(d) does not apply to any rule 
referred to in subparagraph (A) or (B) of section 553(b) of the 
Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.
    APA section 553(b) requires that any rule to which it applies be 
issued only after the public has received notice of, and an opportunity 
to comment on, the rule. However, APA section 553(b)(B) exempts from 
those requirements any rule for which the issuing agency for good cause 
finds that providing prior notice-and-comment would be impracticable, 
unnecessary or contrary to the public interest. Thus, any rule for 
which EPA makes such a finding is exempt from the notice-and-comment 
requirements of both APA section 553(b) and CAA section 307(d).
    EPA believes that the circumstances presented here provide good 
cause to

[[Page 3867]]

take the actions set forth in this final rule without prior notice and 
comment, since providing prior notice and comment would be 
impracticable and contrary to the public interest. Specifically, EPA is 
concerned about health risks to workers associated with the use of HFP 
in replacement refrigerant formulations, in light of recently reviewed 
toxicity data concerning HFP. The data indicate that typical worker 
exposure levels for HFP are above minimal levels of concern for 
noncancer risks. Exposures to HFP have been shown to lead to kidney 
damage. As a result, when HFP is used as a refrigerant or as a 
component in a refrigerant blend, there is a significant chance that 
persons who manufacture, service or dispose of refrigeration and air-
conditioning equipment that contains HFP or an HFP blend may be exposed 
to levels that put them at risk of kidney damage, particularly if they 
have not been specifically trained in the handling of HFP or of blends 
containing HFP. Moreover, since HFP has not historically been used in 
refrigeration equipment, refrigerant technicians generally are not 
trained to handle HFP or HFP blends. Thus, any persons servicing or 
disposing of refrigeration and air-conditioning units that use an HFP-
containing blend would be subject to an actual and immediate health 
risk. The Agency believes that there is a real threat of exposure.
    Several parties have made submissions of HFP-containing 
refrigerants under the SNAP program and the 90-day prohibition on 
marketing has expired. Thus, EPA is concerned that refrigerant blends 
that contain HFP may currently be commercially available and in actual 
use around the nation. As a consequence, the Agency believes that good 
cause exists to take the actions set forth in this final rule without 
prior notice and comment in order to mitigate the risk of exposure to 
this toxic substance.
    As stated in section 612 of the Act, one of the Agency's objectives 
in implementing the SNAP program is to promulgate rules making it 
unlawful to replace any class I or class II substance with any 
substitute that EPA determines may present adverse effects to human 
health or the environment. The Agency believes that HFP and HFP-
containing blends present an unacceptable risk to human health, and 
that immediate action by EPA is necessary in order to mitigate any 
resulting harm. The use of HFP in the refrigeration and air-
conditioning sector will come to a halt most quickly through the 
publication of this interim final rule. In addition, this action, 
combined with Agency outreach and communication efforts, should provide 
any current or potential users of HFP or HFP-containing blends with 
immediate notice that EPA does not consider HFP to be an appropriate 
compound to use in the refrigeration and air-conditioning sector and 
that potential health risks are associated with exposure to HFP during 
the manufacture and servicing of any refrigeration and air-conditioning 
equipment that contains HFP. A full notice-and-comment rulemaking would 
defeat the regulatory objective of the SNAP program to fully ensure 
protection of human health.
    Nonetheless, EPA is providing 30 days for submission of public 
comments following today's action. EPA will consider all written 
comments submitted in the allotted time period to determine if any 
change to this action is necessary.
    Section 553(d) of the APA generally provides that rules may not 
take effect earlier than 30 days after they are published in the 
Federal Register. However, if an Agency identifies a good cause, APA 
section 553(d)(3) allows a rule to take effect earlier, provided that 
the Agency publishes its reasoning in the final rule. Since EPA has 
determined that good cause exists to list HFP and HFP-containing blends 
as unacceptable as a replacement refrigerant, EPA is making this action 
immediately effective in order to ensure the fullest protection of 
human health.

II. Listing of HFP and HFP-Containing Blends as Unacceptable

    As noted above, in light of information recently reviewed by EPA 
concerning the toxicity of HFP, EPA is greatly concerned about the use 
of HFP in replacement refrigerant formulations. EPA has completed an 
HFP risk screen, a copy of which is available in the docket, which 
indicates that its use as a refrigerant or in refrigerant blends will 
pose an unacceptable risk to anyone exposed to HFP during the 
manufacture or servicing of refrigeration or air-conditioning equipment 
that contains HFP or an HFP-containing blend. Because of the extremely 
low occupational exposure limit for HFP, and the fact that worker 
exposure levels for HFP were predicted to be above levels of concern 
for noncancer risks, HFP should not be used in the refrigeration and 
air conditioning sector. It should be noted that today's determination 
has no bearing on the use of HFP or any blend that contains HFP, other 
than as a replacement for a class I or class II substance in the 
refrigeration and air-conditioning sector. Other industrial sectors may 
have safeguards in place to protect against worker exposure to HFP. 
Based on the review of the available toxicity information related to 
HFP, and the results of the EPA risk screen, EPA is today listing HFP 
and all HFP-containing blends as unacceptable for all refrigeration and 
air-conditioning end-uses, whether as substitutes for a class I 
substance such as CFC-12, or as substitutes for a class II substance 
such as HCFC-22.

III. Summary of Supporting Analyses

A. Unfunded Mandates Reform Act and Regulatory Flexibility Act

    Since this action is not subject to notice-and-comment rulemaking 
requirements under the APA or any other law, it is also not subject to 
sections 202, 204 or 205 of the Unfunded Mandates Reform Act (UMRA). In 
addition, since this action does not impose annual costs of $100 
million or more on small governments or uniquely affect small 
governments, the Agency has no obligations under section 203 of UMRA. 
Moreover, since this action is not subject to notice-and-comment 
requirements under the APA or any other statute as stated above, it is 
not subject to section 603 or 604 of the Regulatory Flexibility Act.

B. Executive Order 12866: Review of Significant Regulatory Actions by 
OMB

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this regulatory action is ``significant'' 
and therefore subject to Office of Management and Budget (OMB) review 
and the requirements of the Executive Order. The Order defines 
``significant'' regulatory action as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    OMB has determined that this rule is not a ``significant regulatory 
action'' within the meaning of the Executive Order.

[[Page 3868]]

C. Paperwork Reduction Act

    EPA has determined that this final rule contains no information 
requirements subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et 
seq., that are not already approved by the Office of Management and 
Budget (OMB). OMB has reviewed and approved two Information Collection 
Requests by EPA which are described in the March 18, 1994 rulemaking 
(59 FR 13044, at 13121, 13146-13147) and in the October 16, 1996 
rulemaking (61 FR 54030, at 54038-54039). The OMB Control Numbers are 
2060-0226 and 2060-0350.

D. Executive Order 12875: Enhancing Intergovernmental Partnerships

    Under Executive Order 12875, EPA may not issue a regulation that is 
not required by statute and that creates a mandate upon a State, local 
or tribal government, unless the Federal government provides the funds 
necessary to pay the direct compliance costs incurred by those 
governments, or EPA consults with those governments. If EPA complies by 
consulting, Executive Order 12875 requires EPA to provide to the Office 
of Management and Budget a description of the extent of EPA's prior 
consultation with representatives of affected State, local and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create a mandate upon any State, local, or 
tribal governments. The rule does not impose any enforceable duties on 
these entities. Accordingly, the requirements of section 1(a) of 
Executive Order 12875 do not apply to this rule.

E. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, EPA submitted a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
General Accounting Office prior to publication of the rule in today's 
Federal Register. This rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

F. Executive Order 13045: Children's Health Protection

    This final rule is not subject to E.O. 13045, entitled Protection 
of Children from Environmental Health Risks and Safety Risks (62 FR 
19885, April 23, 1997), because it does not involve decisions on 
environmental health risks or safety risks that may disproportionately 
affect children.

G. Executive Order 13084: Consultation and Coordination with Indian 
Tribal Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to the Office of Management and Budget, in a 
separately identified section of the preamble to the rule, a 
description of the extent of EPA's prior consultation with 
representatives of affected tribal governments, a summary of the nature 
of their concerns, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that significantly or uniquely affect their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. The rule does not impose any 
enforceable duties on these entities. Accordingly, the requirements of 
section 3(b) of Executive Order 13084 do not apply to this rule.

H. National Technology Transfer and Advancement Act

    The National Technology Transfer and Advancement Act of 1995 
(NTTAA), Sec. 12(d), Pub. L. 104-113, requires federal agencies and 
departments to use the technical standards that are developed or 
adopted by voluntary consensus standards bodies, using such technical 
standards as a means to carry out policy objectives or activities 
determined by the agencies and departments. If use of such technical 
standards is inconsistent with applicable law or otherwise impractical, 
a federal agency or department may elect to use technical standards 
that are not developed or adopted by voluntary consensus standards 
bodies if the head of the agency or department transmits to the Office 
of Management and Budget an explanation of the reasons for using such 
standards.
    This proposed rule does not mandate the use of any technical 
standards; accordingly, the NTTAA does not apply to this rule.

IV. Additional Information

    For copies of the comprehensive SNAP lists or additional 
information on SNAP, contact the Stratospheric Protection Hotline at 1-
800-296-1996, Monday-Friday, between the hours of 10:00 a.m. and 4:00 
p.m., Eastern Time.
    For more information on the Agency's process for administering the 
SNAP program or criteria for evaluation of substitutes, refer to the 
SNAP final rule published in the Federal Register on March 18, 1994 (59 
FR 13044). Notices and rules published under the SNAP program, as well 
as EPA publications on protection of atmospheric ozone, are available 
from EPA's Ozone World Wide Web site at http://www.epa.gov/ozone/
title6/snap, and from the Stratospheric Protection Hotline number 
listed above.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Reporting and recordkeeping requirements.

    Dated: January 19, 1999.
Carol M. Browner,
Administrator.

    40 CFR Part 82 is to be amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

    1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. Sec. 7414, 7601, 7671-7671q.

    2. Subpart G is amended by adding Appendix F to read as follows:

Subpart G--Significant New Alternatives Policy Program

* * * * *

Appendix F to Subpart G--Unacceptable Substitutes Listed in the 
Janaury 26, 1999 Final Rule, Effective Janaury 26, 1999

[[Page 3869]]



                       Refrigeration and Air-Conditioning Sector UnacceptabLe Substitutes
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             End-use                    Substitute             Decision                     Comments
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All refrigeration and air-         Hexafluoropropylene   Unacceptable........  Presents unacceptable toxicity
 conditioning end uses.             (HFP) and all HFP-                          risk.
                                    containing blends.
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[FR Doc. 99-1765 Filed 1-25-99; 8:45 am]
BILLING CODE 6560-50-P